TRIGEN 71645045Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556215890), received between Feb 11, 2019 and Oct 9, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, K210980); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE INTRAMEDULLARY NAIL, APPROXIMATELY FIVE ATTEMPTS WERE MADE TO INSERT THE TRIGEN LOW PROFILE SCREW 5.0MM X 45MM, INTO THE STATIC HOLE LOCATED 23 MM PROXIMALLY. HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL BECAUSE THE SCREW JAMMED ONCE INSERTED INTO THE NAIL AND WAS IMPOSSIBLE TO RELEASE FROM THE CAPTURE MECHANISM. THEREFORE, IT WAS DECIDED TO REMOVE THIS SCREW AND NOT INSERT IT. DURING THIS PROCESS, TWO (2) MEDIUM HEXDRIVER WERE USED. THE SCREWS WERE RELEASED WITH THE T-HANDLE. THE PROCEDURE WAS PERFORMED, AFTER A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH AN INCISION AND A PERFORATION WHERE NO SCREW WAS INSERTED, AND THE OTHER TWO STATIC LOCKING OPTIONS, LOCATED 30 AND 40 MM AWAY, WERE INSERTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 23262712 ↗
• InjuryDec 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, FOLLOWING A LEFT IMN FIXATION SURGERY PERFORMED ON TO TREAT A DISPLACED INTERTROCHANTERIC FRACTURE OF THE FEMUR, THE PATIENT SUSTAINED THE BREAKAGE OF THE DISTAL INTERLOCKING SCREW. THE PATIENT WAS ASYMPTOMATIC. ALTHOUGH RECOMMENDED BY THE HEALTHCARE PROVIDER, IT IS UNKNOWN IF THE DISTAL INTERLOCKING SCREW WAS REMOVED AT SOME POINT. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916852 ↗
• InjuryDec 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A BROKEN SCREW AFTER HAVING A FRACTURE FIXATION SURGERY OF A RIGHT FEMUR FRACTURE USING THE TRIGEN TAN SYSTEM. THE PATIENT DID NOT UNDERGO ANY MEDICAL INTERVENTION TO ADDRESS THE ISSUE. THE PATIENT ACHIEVED UNION AT 29.7 WEEKS AFTER THE PRIMARY PROCEDURE. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 16016760 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY HAD BEEN PERFORMED ON 2019, THE PATIENT EXPERIENCED A NON-UNION OF A SUBTROCANTHERIC FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY PERFORM ON (B)(6) 2021, IN WHICH THE META-TAN 10MM X 36CM RIGHT, AND THE SET OF SCREWS: TRIGEN LOW PROFILE SCREW 5.0MM X 40MM, TRIGEN LOW PROFILE SCREW 5.0MM X 45MM AND META-TAN LAG/COMP KIT 95/90 WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. IT IS SUSPECTED THAT PATIENT HAS A BONE DISEASE BECAUSE SHE HAS A COUPLE OF FRACTURES CAUSED BY LOW ENERGY FORCES.

  Patient problems: Failure of Implant

  MAUDE report 13152483 ↗
• InjurySep 23, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER A TRIGEN INTERTAN SYSTEM WAS IMPLANTED ON PLAINTIFF LEFT FEMUR ON (B)(6) 2018, THE PLAINTIFF EXPERIENCED INCREASED PAIN ON LEFT KNEE. BY X-RAYS, FAILURE OF THE DISTAL LOCKING SCREWS, DISTAL MIGRATION OF THE TIP OF THE NAIL AND NONUNION OF LEFT SUBTROCHANTERIC FEMUR WERE FOUND. A REVISION SURGERY WAS PERFORMED ON 07-MAR-2019 TO TREAT THESE ADVERSE EVENTS. INTRAOPERATIVELY, IT WAS FOUND THAT THE PROXIMAL ENDS OF 2 DISTAL LOCKING SCREWS WERE BROKEN. THE TRIGEN INTERTAN COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 12523528 ↗
• InjurySep 3, 2019Break; Break

  IT WAS REPORTED A REVISION SURGERY DUE TO CUT OUT.

  Patient problems: Injury

  MAUDE report 8955429 ↗
• InjuryFeb 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO BROKEN INTERTAN AND THE NON-UNION SUBTROCHANTERIC FRACTURE OF THE LEFT HIP, FEMORAL NECK SHORTENING, MAL REDUCTION.

  Patient problems: Injury

  MAUDE report 8329964 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery